FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIDSPLINT
K Number: K864810
·
Decision Jan 20, 1987
Classifications
1
FEI Numbers
172
Registration Numbers
172
Same Product Code
16
Applicant Total
2
Review Days
42
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Basic Information
- Device Name
- LIDSPLINT
- K Number
- K864810
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4440
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Precision Therapeutics, Inc.
- Date Received
- December 9, 1986
- Decision Date
- January 20, 1987
- Product Code
- HMP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HMP | Pad, Eye | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HMP), ordered by most recent decision date.
EYE PAD
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STERILE,DISPOSABLE EYE DRESSING
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EYE PAD
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FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309
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FDA Class 1
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DONALDSON NATURAL EYEPATCH 'PATIENT PAK'
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FDA Class 1
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SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Precision Therapeutics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K872659 | TAPELESS EYE SHIELD | Jul 27, 1987 | Substantially Equivalent |